U.S. Pat. No. 4,936,851 issued Jun. 26, 1990 to Fox et al., describes a device that allows cancellous bone and marrow as well as organs surrounded by hardened cortical bone to be accessed repeatedly from the same site with minimal surgical trauma and morbidity. The purpose of gaining repeated access was to provide a means for obtaining a significant sample of cancellous tissue for histologic and morphometric analysis.
U.S. Ser. No. 08/357,072, provides a cancellous access port that can be used for repeated biopsies of osseous tissue.
Through repeated use of the prior art devices, failures of the mechanism, difficulty in surgical placement and the inability to acquire a biopsy have been encountered. To overcome these deficiencies; the Bone Biopsy Implant (BBI) (Ser. No. 08/016,908 filed Feb. 12, 1993), since issued as U.S. Pat. No. 5,405,388, Apr. 11, 1995 was conceived. The bone biopsy implant forms a port allowing endoscopic access to the medullary compartment.
In the prior art, bone implants have been used to solve health care problems of orthopedic and maxillofacial reconstruction, prosthesis and denture fixation, and fracture stabilization. Additionally, bone implants have been developed to advance the knowledge of bone healing and remodeling as well as the interaction of bone and implant material or devices.
Prior art includes an optical titanium chamber disclosed by Albrektsson in 1979, a bone ingrowth chamber (Albrektsson et al., U.S. Pat. No. 4,880,006, Nov. 14, 1989), and a bone harvest chamber (hereinafter sometimes called the "BHC") (Kalebo in 1987) all of which were developed at the University of Goteborg, Sweden. Prior art devices provide a means for obtaining permanent atraumatic access to otherwise inaccessible biological tissues which are protected or covered by hardened bone structures. However, their capability to obtain a biopsy of cortical bone or cancellous tissue following complete healing and mineralization of this tissue is severely compromised by their design.
The osseous infusion capability of the implant system builds on the use of long bones for acute access to the cardiovascular system which dates back to 1922 when Drinker first suggested the sternum as an infusion route. In the early 1940's, Tocantins laid the basis for widespread application of tibial and sternal routes for the administration of fluids to the cardiovascular system.
Building on Tocantins work Meloa, Heinild and Papper demonstrated clinical application of this route for access to the vascular system in children and adults. Heinild reported the use of a needle to infuse 495 patients in which 982 procedures were performed to treat seventeen indications and one general category of disease. In this three year study, only eighteen unsuccessful attempts were reported. Though deaths of patients in the treatment groups were reported, none were specifically attributed to the infusion procedure. In this group of patients, the majority received multiple infusions with one individual receiving as many as ten. Historically, a wide range of fluids have been infused (blood, serum, saline, etc.). Irritation and pain were reported with the infusion of hypertonic solutions. This observation indicates there might be a considerable risk of osteomyelitis when hypertonic solutions are infused via this route.
Complications with these procedures were reported. Heinild reported that clinically, 8.2% of the initial attempts to enter the medullary cavity with a needle failed. Cases in which multiple attempts were made to enter the medullary cavity, only 1.8% were a complete failure. Some cases reported a large hematoma on the posterior aspect of the leg suggesting that the needle had been pushed through the bone. Swelling and oozing around the entry site were noted suggesting that retrograde flow around the needle was occurring. Technical difficulties such as bending and sticking of the needle were also reported. In a 1985 review of the procedure, Rosetti summarized reports by 30 authors between 1942 and 1977 of 4359 attempted infusions. Of these 4359 attempts, 89 were complete failures. Additionally, 27 incidences of osteomyelitis and 10 other complications occurred.
Presently, cannulation is used as a standard method for emergency resuscitation for infants. Valdes reported its use in 15 adults with a mean age of 50.46 years. Shoor investigated the pressure-flow relationship and pharmacokinetics of the procedure. Infusion rates from 102 to 2,500 ml/hour were reported with gravity feed and pressures up to 300 mmHg in the tibia and sternum. Rosetti reported data on infusion rate, fluids administered, uses, complications and suggested intraosseous infusion as an alternative route for pediatric intravascular access. The American Heart Association supports Rosetti's recommendations and suggests the procedure as a recommended alternative for circulatory support for pediatric care.
In the prior patent art an implant invented by Von Hoff et al. entitled "Intramedullary Catheter" (U.S. Pat. No. 4,772,261) is described. This patent describes a method and bone implant device to facilitate osseous infusion. The intramedullary catheter (IC) patent claims a method that uses an elongated, tubular conduit, and a head attached to one end of the conduit. Dependent claims describe a sealing mechanism disposed in the cavity to overly the conduit. The combination of the elongated, tubular conduit, head, cavity and sealing mechanism were well known in the technical literature but were novel due to their combination as a permanent implantable device.
The title intramedullary catheter and claims describe a device that resides in bone marrow and relies on a tubular conduit connected to the outside of the bone to facilitate infusion. Blockage of this conduit would and in reports has caused the device to fail during human and animal use. The internal volume of the conduit and cavity form dead space within the human body. The body naturally tries to fill this space which results in blockage of the device and its failure to facilitate osseous infusion. The dead space formed by the conduit and cavity provide an region within the implant that is prone to microbial colonization and intractable infection.
The principal deficiencies of the IC are conduit and cavity blockage, microbial colonization, exfoliation of the implant, difficulty in surgical placement and the inability to replace the sealing means or clear the device without explantation. Explantation of the device generally damages the surrounding bone leaving the site unsuitable for future use.
The subject invention of the present patent application is related to the bone biopsy implant. The present disclosure details the use of devices for endoscopic and other access and includes teaching for minimally invasive surgical manipulation of bone. The subject invention expands on the use of the bone biopsy implant for endoscopic access to the medullary compartment by describing a method of performing bone surgery, viewing bone and marrow tissue, delivering materials to bone and fluids into the cardiovascular system and aspirating fluids from a patient through an implant that forms a port through a surgically created defect in bone tissue.